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Justinian Lane

The Under-funded, Under-staffed FDA

Just yesterday, Ted Frank suggested that I was wrong, and the FDA wasn't suffering from staffing and funding problems.  Just hours later, the Associated Press posts an article explaining that yes, the FDA is under-staffed and under-funded.  And the pharmaceutical industry shares part of the blame:

WASHINGTON (AP) -- When pharmaceutical consulting firm Quintiles wants to hire a new employee, the first place it looks is the Food and Drug Administration.

These former insiders bring critical expertise to the consultant and clients like Merck & Co. Inc. and Pfizer Inc., but there is also an unintended downside.

As companies siphon off FDA's most experienced scientists, they leave an increasingly leaner, less confident staff that is hesitant to put new drugs on the market, analysts say.

....

"What you have now is a big sucking sound of these staffers leaving FDA and going into the more lucrative side of the business or packing it in and retiring entirely," said Steve Brozak, an analyst with WBB Securities. "This cannot have any positive effect whatsoever."

FDA has repeatedly rejected criticisms from Wall Street and pharmaceutical companies that drug approvals have slowed in recent years. Instead, the agency says companies are submitting fewer new drug applications.

FDA's leadership is scrambling to recruit a new generation of food and drug regulators, as the average age of FDA's 10,100-person work force reaches 54. Thirty percent of the agency's regular staff are already eligible to retire and FDA expects to hire 600 staffers by October to replace those leaving.  (Emphasis added.)

FDA's outside advisers say frustration with FDA culture is a major reason its turnover rate is twice that of other agencies.

Staffers who disagree with management are reportedly discouraged from speaking up, according to an Institutes of Medicine report on FDA's drug safety system. (Emphasis added.)

....

FDA's outside advisers point the blame for staffing problems toward the White House and Congress, which have heaped new responsibilities on the agency without increasing its funding.

In the last 15 years, FDA has received more than 100 new assignments, but the number of government-provided staffers has fallen from roughly 9,000 to 8,000. The result is less regulation even as the industries FDA oversees grow larger. (Emphasis added.)

The image of an overburdened agency has not made things easier for FDA recruiters, who are crisscrossing the country seeking applicants with science backgrounds.

At the center of the staffing effort is a proposed fellowship program that would bring 2,000 scientists and doctors into the agency every two years, with the goal of convincing some to stay on.

But with no funding set aside for the program, even those pulling for FDA are skeptical. (Emphasis added.)

....

"If you look at the 20,000 medical students graduating each year, only a very small portion would even be interested in a career that leads to a government agency," said Michael Ehlert, president of the American Medical Student Association.

The danger of dwindling inspections hit home earlier this year when FDA said contaminated heparin from Baxter International Inc. was associated with as many as 81 deaths and hundreds of allergic reactions.

FDA didn't inspect the Chinese plant where the blood thinner was produced due to a bureaucratic mix-up involving a factory with a similar name.

While FDA records list 3,249 foreign drug manufacturers subject to inspections, it can't tell if it has inspected two thirds of them, according to Government Accountability Office investigators.

The agency may soon get an injection of much-needed funds.  (Emphasis added.)

After weathering nearly weekly scoldings from lawmakers, FDA Commissioner Andrew von Eschenbach asked Congress last month for an emergency $275 million to supplement this year's $2.3 billion fiscal budget. (Emphasis added.)

Source: FDA's brain drain clogs drug-approval pipeline: Financial News - Yahoo! Finance

So to recap: The FDA is short on money and staff.  Much of the staff that it does have lacks the necessary skills and experience to (a) approve drugs in a timely manner and (b) protect the public from unsafe products and facilities.  Because the pharmaceutical industry pays much better than government, it's doubtful that the FDA will be able to attract and retain the top-notch doctors and scientists it needs to fulfill its mission.  A mission that has expanded dramatically without any concomitant increase in funding or staff, by the way.

Articles like this illustrate why FDA preemption is a bad idea.  If we're going to put the FDA completely in charge of drug safety and eliminate the tort system, shouldn't we make sure that the agency has the right people and the right amount of funding to protect the public? 

Justinian Lane: Author Bio | Other Posts
Posted at 10:44 AM, Jun 04, 2008 in Pharmaceuticals | Preemption
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Comments

If you do not want the FDA to be in charge of drug safety, who do you suggest? Further, why would you then argue that a drug has to be FDA approved or at least even be prescribed and marketed for a given indication.

Do you feel that if we gave the FDA more people and money that then 'preemption' would be good? What is your solution?

Posted by: throckmorton | June 4, 2008 11:24 AM

I do believe the FDA should be in charge of drug regulation. I don't under any circumstances believe that preemption is good public policy. But I also suggest that if we're going to make preemption happen, we shouldn't do it until the FDA has the staff and funding necessary to do its job properly. I would suggest paying competitive salaries to its staff, funding it enough that it doesn't need to rely on fees from pharma, and funding it enough that it conducts its own studies, rather than relying on industry. I'd also grant it subpoena power, which it currently does not have. I would further implement restrictions upon leaving the FDA to work for pharma, similar to the restrictions we have upon becoming a lobbyist.

To put it in perspective, we spend more on the Iraq war in a single day than the FDA gets all year. (2.4 billion for Iraq, 2.3 billion for the FDA.)

Posted by: Justinian Lane | June 4, 2008 11:55 AM

The FDA is a serious threat to the health of the public, and should be eliminated by law. The lawyers there and their running dog technocrats obstruct innovation. They fail to prevent food poisoning. They are a failure from every direction. All but the most lethal and addictive medications should go over the counter. Data from foreign trials should be posted on the web. Critics of such data may weigh in. The public may judge the risks and benefits for itself. This crypto-Commie, politically oppressive organization has kept medical progress back by several decades. It is a scam. Its regulations are a form of unapproved human experimentation with ghastly outcomes.

In exchange for banning the FDA, the term of all drug patents should shorten to five years, a reflection of the rate of change in our era.

Posted by: Supremacy Claus | June 4, 2008 12:03 PM

"Ted Frank suggested that I was wrong, and the FDA wasn’t suffering from staffing and funding problems."

Justinian, while I regularly state that you are wrong, at no point did I take a position on whether the FDA was "suffering from staffing and funding problems." Stop invoking my name for positions I'm not taking, especially when you refuse to address the positions I actually take. It's disgustingly dishonest of you.

Posted by: Ted | June 4, 2008 2:08 PM

Ted, you stated in another comment thread that the problem with FDA regulation isn't underfunding. If I misstated your position, I apologize. But that makes your position all the worse: Why would you argue in favor of FDA preemption if you agree the agency lacks the staff and funding to carry out its mission?

Posted by: Justinian Lane | June 4, 2008 2:29 PM

"its mission"

You say that as if the FDA only has one mission. Didn't you read the article you just quoted? It agrees with me: "In the last 15 years, FDA has received more than 100 new assignments" -- i.e., the problem with the FDA is that it is overregulating. It wouldn't be understaffed if it weren't engaged in so much counterproductive activity.

And why do you keep asking dishonest rhetorical questions misstating my position when there's a Supreme Court brief with my name on it spelling out my position? The fact that you refuse to address my actual position on preemption suggests you have no counterargument.

Posted by: Ted | June 4, 2008 4:50 PM

It seems to me that you're trying to have it both ways: On the one hand, you want the FDA to regulate less. But on the other hand, you don't want injured consumers to be able to be compensated for their injuried when the FDA commits a Type I error. Seems like patient safety gets the short end
of that stick.

Oh. Your brief is chock full of factual omissions and non sequiturs. I should have a response to your brief posted before the end of the week.

Posted by: Justinian Lane | June 4, 2008 5:16 PM

I'm still waiting for you to correct the smear of me in your post.

Posted by: Ted | June 4, 2008 6:52 PM

Ted, if you want me to correct anything, then answer these questions with no hedging:

Given its current missions, do you believe the FDA is funded adequately? And given its current missions, do you think the FDA is staffed adequately?

...smear... you're so touchy.

Posted by: Justinian Lane | June 4, 2008 8:28 PM

I've never taken any position on FDA budgeting issues.

I'm still waiting for you to correct the smear of me in your post.

Posted by: Ted | June 4, 2008 9:06 PM

Boys, boys, shushish.

You are both victims of criminal cult indoctrination.

Ted has an IQ that is the sum of Justinian's and mine. However, he is still a victim. He accepts the central doctrines of the law. They are Medieval garbage. That makes their disputes similar to arguments over angels on the head of a pin. Garbage.

Posted by: Supremacy Claus | June 5, 2008 9:05 AM